FDA recalls GLP-1 drug, other injectable medication over sterility concerns
A woman holds a slimming syringe from Eli Lilly with the name Mounjaro and the active ingredient tirzepatide. Photo: Christoph Reichwein/dpa (Photo by Christoph Reichwein/picture alliance via Getty Images)
Apothecary Pharma is recalling 23 vials of injectable drugs distributed nationwide because their sterility cannot be guaranteed, according to the Food and Drug Administration.
Dig deeper:
The voluntary recall includes 22 vials of compounded tirzepatide, a GLP-1 medication with the same active ingredient as Eli Lilly’s Mounjaro and Zepbound, as well as one vial of NAD+ injection. The FDA classified the recall as Class II on Oct. 8, meaning serious health problems are unlikely.
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The recall comes after the FDA sent Apothecary Pharma, a North Carolina company, a warning letter in December 2025 citing serious deficiencies in its sterile drug manufacturing practices. The agency said the issues posed risks to patients but has not linked those findings to the current recall.
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The affected tirzepatide is an 18 mg/mL prescription injection packaged in a 4 mL multidose vial. Its NDC number is 85091-001-18. Recalled lots include AP-202622 through AP-202625 and AP-202627 through AP-202644, with beyond-use dates ranging from Oct. 7 to Nov. 26, 2026.
The recalled NAD+ injection is a 200 mg/mL prescription product packaged in a 6 mL multidose vial. Its NDC number is 85091-011-06. The affected lot is AP-202647, with a beyond-use date of Oct. 13, 2026.
Apothecary Pharma began the recall Sept. 24 and notified recipients by letter. The recall is ongoing.
What you can do:
Consumers should check their vials or pharmacy records, stop using any affected products and contact their pharmacist or prescriber for guidance. Anyone who experiences fever, redness, swelling or worsening pain after receiving an affected injection should seek medical attention.
The FDA notice did not report any illnesses or injuries associated with the recalled products.
The Source: FOX Business contributed to this report. The information in this story came from a recall notice issued by the Food and Drug Administration. This story was reported from Los Angeles.